ERI RICE C E CALL F L FOR R CHANGE GE UTILI LISING PATIENT EX - - PowerPoint PPT Presentation

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François Houÿez

virtual joint PCWP-HCPWP meeting, 24 June 2020

ERI RICE C E CALL F L FOR R CHANGE GE UTILI LISING PATIENT EX EXPERIENCES T TO EN ENHANCE T THE E QUALITY TY AN AND S SAFE FETY TY O OF H HEALTH THCARE

Rethinking Causality, Complexity and Evidence for the Unique Patient!

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ERI RICE

A FOU OUND NDATION F N FOR OR RESEARCHERS

The Ettore Majorana Foundation and Centre for Scientific Culture embraces 128 schools, covering all branches of Science. The Centre is situated in the old pre-mediaeval city of Erice in four restored monasteries It hosts the International School of Pharmacology (ISP) "Giampaolo Velo" ISP organises workshops on various topics, such as the safe use of drugs, drug innovation, medication errors, communication regarding drugs, patient safety…

THE E HE ERICE E DECLARA RATION

The Erice Declaration on Communicating Drug Safety Information was first published in September 1997. It provides a vision of vigorous, open, ethical, patient-centred communications in drug safety that the world has yet to achieve. Republished Drug Safety 2006; 29 (2): 1

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• bjectives

The aim of the meeting was to discuss the challenge of causal complexity and individual variation in modern healthcare Two patients take the same drug at the same dose. One has an adverse drug reaction, the other hasn’t.

• Is it all explained by the “omics”? Can

Big Data help?

• Or can the patients tell us something

that helps understand why one has it, but not the other one?

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THE GROUP CONCERNS

• The impact that new clinical

decision-making tools, based on statistical correlations in large databases, could have on individual patient care if they replace other types of clinical investigation and knowledge

• It needs to be evaluated in light of

the unique and complex reality of the individual receiving care

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Main question

• How should clinical practice

and research gather and utilise rich narratives of patients’ individual experiences to improve general medical and therapeutic knowledge and patient safety?

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Person-centred healthcare that is also evidence-based must take account of the multiple causal mechanisms and contextual factors that can affect the treatment of a single patient in their unique circumstances

The Approach to Patient Care

Such person-centred healthcare should consider more than just the normative data from controlled studies that are not likely to be generalizable to all individuals

Evidence not just normative

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Some challenges

Interventions that benefit or harm the community as a whole will not necessarily benefit or harm each member of that community

Public health versus individuals

How to ensure transparency of possible conflicts of interest (financial, religious, institutional, political, etc.) among clinicians and institutions that might affect their interpretation of causal evidence, their clinical decisions and their patients

Conflicts of different nature

How to ensure the humane and visionary purposes of traditional practice are not lost in an era of accelerating change

Human medicine and technological progress

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Patients should feel they get the treatment that is most accurately tailored to their individual needs Challenges: Restrictions of a healthcare system in which time constraints, bureaucracy and cost efficiency drive practice

Ensuring Best Outcomes of Patient Care

Causal considerations in patient safety, including drug safety and toxicity, must be focused on the particular individual by prioritising rich qualitative narratives of their context, history and experience

Tailored treatments Listening to patient

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Narratives

Often dismissed

as causally irrelevant because

• f their anecdotal

nature

And yet

Well-documented spontaneous adverse reaction reports with narratives are valuable

We should

Collect, analyse and use them qualitatively in a practical, accessible system, in an agreed format that is compatible with high ethical standards

Make more use

So that they can be used as important qualitative evidence regarding causation

Of them

For example: ADR reports narratives are not translated, not transmitted to EudraVigilance or the MAH

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A CASE

ACUTE KIDNEY FAILURE AND PHARMACOVIGILANCE

Routine blood exam Acute kidney failure diagnosed Patient treated with ibuprofen, emtricitabine/tenofovir disoproxil fumarate, diltiazem, perindopril/indapamide All associated with some risk of kidney dysfunction Nephrologist consulted databases to see if any synergistic effect Medical advice: to stop ibuprofen Otherwise risk of kidney dialysis in less than 10 years When in fact the patient insisted he had been exposed to high temperatures in recent days And he rarely feels thirsty (hypodipsia) So finally patient increased water intake 24h later: renal function went back to normal

THE IMPORTANCE OF LISTENING TO THE PATIENT

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Patients should be invited to take an active role in their own healthcare, characterised by genuinely collaborative and egalitarian communication.

Patients to play an active role

They can be empowered by participating in transdisciplinary networks, with healthcare professionals working to push current thinking forward

Equal credibility As other experts

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AFTER ALL, WHAT IS THE MOST USEFUL FOR AN INVESTIGATION?

• The most important in a crime

investigation?

• Questioning all witnesses: 90% of the

investigation

• The most important for a medical

diagnosis?

• Questioning the patient, physical exam:

90% of the medical reasoning

• Exams are secondary

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The process

participants

• Participants were selected by the organising

committee on the basis of their broad interest and expertise in the discussed topics and representing their own views:

• scientific researchers, epidemiologists,

clinicians, pharmacists, decision makers, drug manufacturers, communications specialists, patients and philosophers of science

• Rani Lill Anjum, Norway; Jean-Christophe Delumeau,

Singapore; Ivor Ralph Edwards, Sweden; Birgitta Grundmark, Sweden; Kai Brynjar Hagen, Norway; François Houÿez, France; Bruce Hugman, UK; Tobias Gustum Lindstad, Norway; Marie Lindquist, Sweden; Matthew Low, UK; Ugo Moretti, Italy; Eugenio Paci, Italy; Christine Price, UK; Elena Rocca, Norway; Lovisa Sandberg, Sweden; Ruth Savage, New Zealand; Penny Sawell, UK; Anders Sundström, Sweden

Find the Erice Call for Change

• Drug Safety (2020) 43:513–515

https://doi.org/10.1007/s40264-020-00919-2 Erice Call for Change: Utilising Patient Experiences to Enhance the Quality and Safety of Healthcare Elena Rocca · Rani LillAnjum Published online: 15 April 2020

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Thank you for your attention.

Director of Treatment Information and Access francois.houyez@eurordis.org

François Ho Houÿez